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Alere to Develop Simple, Affordable Point-of-Care Nucleic Acid Test for Tuberculosis

Published: Tuesday, March 05, 2013
Last Updated: Tuesday, March 05, 2013
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Alere Inc. announced that it has been awarded a grant of up to $21.6 million and debt financing of up to $20.6 million from the Bill & Melinda Gates Foundation.

The $21.6 million grant will fund the development of a tuberculosis assay, which will be designed for use in both resource-constrained and well-resourced settings. It will also support the company’s efforts to incorporate one of its isothermal amplification technologies for TB detection onto the Alere™ Q, a compact, portable, and robust device intended for molecular testing at the point of care. In addition, the Gates Foundation will provide below-market loans of up to $20.6 million for the expansion and scale up of Alere’s manufacturing facilities in Jena, Germany for both the POC TB Nucleic Acid Test and the POC HIV Viral Load Test currently in the final stages of development. The Gates Foundation will provide these loans in exchange for commitments from Alere to make these diagnostics available at an affordable price to people in need in developing countries.

Tuberculosis is a leading cause of death worldwide, and nearly 8.8 million cases of TB occur each year, mostly in middle-income and low-income countries. Today, laboratory-based technologies provide the primary means for diagnosing the illness, but these technologies often fail to identify large numbers of active cases, take weeks to deliver results, lack crucial drug resistance information, or are unable to meet the needs of individuals with limited access to lab facilities. Alere’s collaboration with the Gates Foundation will produce a highly sensitive, low-cost diagnostic that can be implemented in lower-level laboratories or outside the lab altogether.

A world leader in near-patient diagnostics, Alere is committed to developing solutions that support screening for the world’s most burdensome diseases, such as TB and HIV, and support the ongoing monitoring of people living with HIV or HIV-related conditions like TB.

Alere will deploy a previously acquired isothermal amplification technology for TB detection and is developing a molecular device, the AlereTM Q, which is currently in clinical trials, to support near-patient molecular testing for HIV. Merging these technologies in a single platform will play an invaluable role in combating the TB epidemic. The platform will offer the high-performance sensitivity and specificity needed to diagnose individuals with TB accurately. Moreover, it may be used for strain and antibiotic resistance typing at the point of care, which should ultimately serve to improve patient management and fight the spread of drug-resistant strains. Compact design, battery-powered portability, and ease of use will make the AlereTM Q ideal for even the most basic healthcare settings.

Furthermore, Alere’s highly automated manufacturing processes will ensure that both the instrument platform and consumables can be produced at an accessible price that enables widespread adoption. Since the introduction of its revolutionary Alere™ CD4 product in 2010, Alere has built the manufacturing site in Jena, Germany, into a center of excellence for instrument-based, point-of-care diagnostics. As part of the agreement, HIV test manufacturing will be fully automated and scaled to the level needed to make the product globally accessible.

Commenting on the award, Alere CEO Ron Zwanziger said, “Providing affordable products that transform the way medicine is practiced, especially in resource-limited settings, is part of Alere’s heritage. There is a critical need for near-patient diagnostics that accurately identify TB cases and facilitate effective management to keep the condition under control. We are very excited to have the support of the Gates Foundation in fighting one of the most dangerous infectious diseases, and we remain committed to providing solutions that improve health outcomes for individuals living with HIV.”

“Although significant progress has been made in combating tuberculosis over the past 25 years, it remains one of the leading causes of death worldwide. To provide earlier treatment and prevent the spread of TB, we need fast, accurate diagnostic tools that can be easily implemented in resource-limited environments,” said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. “Alere has a track record of diagnostic innovation and leveraging cost-effective technologies to improve health outcomes for individuals living with HIV in the most remote parts of the world. The Gates Foundation has put its support behind the company to apply these same principles in addressing the TB epidemic and potentially saving millions of lives.”

Development on the TB assay has commenced, and validation for its use is expected within the next 24 months.

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